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Chest Compression and Sustained Inflation

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ClinicalTrials.gov Identifier: NCT02083705
Recruitment Status : Completed
First Posted : March 11, 2014
Last Update Posted : January 9, 2017
Sponsor:
Information provided by (Responsible Party):
University of Alberta

Tracking Information
First Submitted Date  ICMJE January 13, 2014
First Posted Date  ICMJE March 11, 2014
Last Update Posted Date January 9, 2017
Study Start Date  ICMJE January 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2014)
Time needed to achieve Return of Spontaneous Circulation [ Time Frame: within the first 10 minutes after birth ]
We aim to reduce time needed to achieve Return of Spontaneous Circulation. This should be achieved by the experimental chest compression technique
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Chest Compression and Sustained Inflation
Official Title  ICMJE Chest Compression and Sustained Inflation for Asystole or Bradycardia in Newborn Infants
Brief Summary Guidelines on neonatal resuscitation recommend 90 chest compressions (CC) and 30 manual inflations (3:1) per minute in newborns. The study aimed to determine if CC s during sustained inflations (SI) improves recovery of asphyxiated newborns compared to coordinated 3:1 resuscitation.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Newborn Infants Having Asystole or Bradycardia at Birth
Intervention  ICMJE
  • Procedure: CC+SI
    Chest compression will be superimposed by sustained inflation during CPR
  • Procedure: 3:1 CPR
    CPR using 3:1 ratio (control group)
Study Arms  ICMJE
  • Experimental: SI+CC

    Chest compression will be superimposed by sustained inflations during CPR:

    "CC+SI group" Infants randomized in the SI group requiring CC, would receive CC at a rate of 90/min during an SI with a duration of 20sec (CC+SI). After 20 sec the SI will be interrupted for 1 sec and the next SI will be started for another 20sec13. Throughout this time CC is continued until ROSC. Every 45 sec (approximately 2 SIs) the clinical team would assess for changes in heart rate. CC+SI was continued until ROSC.

    Intervention: Procedure: CC+SI
  • Active Comparator: 3:1 CPR

    CPR using 3:1 C:V ratio:

    "3:1 C:V group" Infants randomized into the "3:1 group" requiring CC, would received CC using the current 3:1 C:V ratio recommend in the neonatal resuscitation guidelines16. Every 45 sec the clinical team would assess heart rate. 3:1 C:V CPR was continued until ROSC.

    Intervention: Procedure: 3:1 CPR
Publications * Schmölzer GM, O Reilly M, Fray C, van Os S, Cheung PY. Chest compression during sustained inflation versus 3:1 chest compression:ventilation ratio during neonatal cardiopulmonary resuscitation: a randomised feasibility trial. Arch Dis Child Fetal Neonatal Ed. 2018 Sep;103(5):F455-F460. doi: 10.1136/archdischild-2017-313037. Epub 2017 Oct 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 30, 2014)
10
Original Estimated Enrollment  ICMJE
 (submitted: March 6, 2014)
20
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Newborn infants with asystole Newborn infants with bradycardia

Exclusion Criteria:

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 3 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02083705
Other Study ID Numbers  ICMJE Pro00034524_CC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Alberta
Study Sponsor  ICMJE University of Alberta
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Georg Schmolzer University of Alberta
PRS Account University of Alberta
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP